Amplatzer Amulet Gebrauchsanweisung Seite 13

100105566_Amulet.book Page 6 Tuesday, May 20, 2014 1:05 PM
39. Connect the delivery cable to the exposed proximal end screw of the device. Grasp the
loader and device and rotate the delivery cable clockwise to thread the device onto the
delivery cable. Stop rotating the delivery cable when resistance is felt.
40. Immerse the device in sterile saline.
41. Pull the loading cable vise until the device is loaded into the proximal end of the loader.
Note: Do not pull the device to the distal end of the loader.
42. Remove the loading cable by rotating the loading cable vise counterclockwise.
43. Return to Step 9.
Post-Procedure Instructions
• Monitor the patient overnight. Do a transthoracic echocardiography (TTE)/follow up to make
sure the device is in the correct position and no pericardial effusion is present before the
patient is discharged.
• Aspirin (or an alternate antiplatelet) is recommended for patients for 6 months post implant.
The decision to continue this regimen after 6 months is at the discretion of the physician.
• Clopidogrel (or an alternate antiplatelet) is recommended for patients and prescription
should follow routine standard of care.
WARNING: An anticoagulation and/or antiplatelet regimen is recommended to reduce
risk of adverse events, including intracardiac thrombus.
• Appropriate endocarditis prophylaxis is recommended.
• Instruct the patient on when to seek medical attention.
• Provide routine standard of care follow-up, including echocardiography, for evaluation of
residual shunt and adverse events (including thrombus formation).
• Go to www.amplatzer.com/tempIDcard/ to print the temporary patient identification card.
Complete this card and give it to the patient.
Disposal
• The carton and Instructions for Use are recyclable. Dispose of all packaging materials as
appropriate.
• Devices can be returned to AGA Medical for disposal. Contact an AGA Medical
representative or returns@amplatzer.com for instructions.
• Use solid biohazard waste procedures to discard devices.
Warranty
AGA Medical Corporation warrants to buyer that, for a period equal to the validated shelf life of the
product, this product shall meet the product specifications established by the manufacturer when
used in accordance with the manufacturer's instructions for use and shall be free from defects in
materials and workmanship. AGA Medical Corporation's obligation under this warranty is limited to
replacing or repairing at its option, at its factory, this product if returned within the warranty period
to AGA Medical Corporation and after confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, AGA MEDICAL CORPORATION
DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
See the Terms and Conditions of Sale for further information.
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